A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine
Completed · Not applicable
Conditions studied: Toxoplasmosis, Cerebral, HIV Infections
In brief
To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate conventional therapy.
Key facts
- Study ID
- NCT00001994
- Run by
- Glaxo Wellcome
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have the following:
- Presumptive diagnosis of AIDS.
- Cerebral toxoplasmosis.
- Expected survival of at least four weeks without therapy.
- Willing and able to give informed consent.
- Prior Medication:
- Allowed:
- Pyrimethamine-sulfonamide.
- Clindamycin-sulfonamide.
You may not qualify if…
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Significant emotional disorder or psychosis.
- Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
- Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
- Ensure Plus) or pulverized form through a nasogastric tube.
- Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
- Concurrent Medication:
- Excluded:
- Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
- First three weeks of treatment:
- Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:
- ddI,ddC).
- Patients with the following are excluded:
- Significant emotional disorder or psychosis.
- Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
- Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
- Ensure Plus) or pulverized form through a nasogastric tube.
- Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
- Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Where it is running
- Los Angeles County - USC Med Ctr — Los Angeles, California, United States
- Infectious Disease Med Group — Oakland, California, United States
- San Francisco Gen Hosp — San Francisco, California, United States
- UCSF - San Francisco Gen Hosp — San Francisco, California, United States
- Davies Med Ctr — San Francisco, California, United States
- Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
- Infectious Disease Research Consortium of Georgia — Atlanta, Georgia, United States
- Johns Hopkins Hosp — Baltimore, Maryland, United States
- Beth Israel Med Ctr — New York, New York, United States
- Saint Vincent's Hosp and Med Ctr — New York, New York, United States
- Harlem Hosp Ctr — New York, New York, United States
- SUNY / Health Sciences Ctr at Stony Brook — Stony Brook, New York, United States
- Duke Univ Med Ctr — Durham, North Carolina, United States
- Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
- Regional Med Ctr at Memphis — Memphis, Tennessee, United States
- Gathe, Joseph, M.D. — Houston, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
- Infectious Disease Physicians Inc — Annandale, Virginia, United States
- Southern Alberta HIV Clinic / Foothills Hosp — Calgary, Alberta, Canada
- Dr Julio S G Montaner — Vancouver, British Columbia, Canada
- Wellesley Hosp — Toronto, Ontario, Canada
- Dr Emil Toma / Hotel Dieu de Montreal — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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